Drugs

CGMP Issues at AuroLife Pharma New Jersey Facilities

A 1/13-2/12 FDA inspection at two AuroLife Pharma drug manufacturing facilities in Dayton, NJ, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 10/16 Warning Letter says specific violations were:

failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch had already been distributed;
failing to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair;
failing to establish and follow written procedures for cleaning and maintaining equipment; and
failing to establish adequate written procedures for production and process control designed to assure that the drug products the firm manufactures have the identity, strength, quality, and purity they purport or are represented to possess.

FDA says that based on the nature of the violations identified at the facilities, it strongly recommends the company engage a qualified consultant to assist it in meeting CGMP requirements.

AuroLife was told to respond with a list of specific steps it has taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completing the corrections.

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome